Indocyanine Green (ICG) Guided Tumor Resection

Phase 1

Recruiting

• Conditions: Neoplastic Disease; Solid Tumor
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT04084067
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible.

Primary Objective

To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories:

1. Osteosarcoma

2. Ewing Sarcoma

3. Rhabdomyosarcoma (RMS)

4. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

5. Neuroblastoma

6. Renal tumors (Only bilateral Wilms Tumor patients will be included.)

7. Metastatic pulmonary deposits

8. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

Exploratory Objectives

1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.

2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.

3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.

4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.

Detailed Description

This trial is a single center open-label study. Patients with a solid tumor or lymphoma who require resection either for therapeutic or diagnostic intent will be included.

Indocyanine Green (ICG) is an FDA-approved drug. Prior to surgery, patients will receive a single dose of ICG intravenously.

During surgery, after the surgeon identifies the mass through visual (seen with the naked eye) and or tactile methods (palpated), the patient will have his/her tumor field imaged by Iridium system optimized for detection of ICG (Visionsense Corp, Philadelphia, PA). The entire procedure will be photo- documented and recorded.

The Visionsense system records images in real time, calculates percentages, and captures the data. At least three different areas of the tumor will be measured. If the tumor cannot be identified by visual inspection or palpation, NIR-imaging will be used in an attempt to locate the lesion. The surrounding area will be inspected and measured to screen for additional sites of metastatic disease. After tumor resection, residual fluorescence in the surgical resection bed will be measured.

Direct subject participation in the trial will last for the period of time from injection of the ICG the day before surgery and until 24 hours post-surgery.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Study Start: 2020-02-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.

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Exclusion Criteria

• Subjects with a history of iodide allergies, including positive allergic reaction to the screening iodine test.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Patients with benign pathology.
• Patients with brain tumors.
• Pregnant female.
• Patients with unilateral Wilms Tumor.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indocyanine green (ICG)	Indocyanine Green	Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity rates of the ICG guided neoplastic disease identification	up to 24 hours post-surgery	The 312 patients (39 patients in each of the 8 categories) will be evaluated for this objective.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States